Randomized Controlled Trial of the Alma Peer Mentoring Program for Pregnant Women Experiencing Depression

Depression Clinical Trial

Official title:

The Effectiveness of the Alma Peer Mentoring Program for Pregnant Women With Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02883686
• Other study ID #: CO-16-2391
• Status: Completed
• Phase: N/A
• Start date: February 6, 2019
• Est. completion date: April 28, 2020

Study information

• Verified date: May 2020
• Source: University of Colorado, Boulder
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Women have double the odds of getting depressed as men and commonly experience depression during the childbearing and early parenting years. Many new and expectant mothers who experience depression never receive help. Alma is a new program, collaboratively developed by a team of researchers, clinicians, and mothers who have personal experience with depression, to support women experiencing depression during pregnancy and the postpartum period. In the Alma program, mothers who themselves have experienced and recovered from depression during the perinatal period, are trained to provide peer mentoring to depressed new and expectant mothers. Peer mentors are trained by professionals who are experts in using skills to recover from depression. These skills are informed by an evidence-based framework called Behavioral Activation (BA). Peer mentors do not provide psychotherapy and are not licensed mental health providers.

Description:

Women have double the odds of getting depressed as men and commonly experience depression during the childbearing and early parenting years. Many new and expectant mothers who experience depression never receive help.

Alma is a new program, collaboratively developed by a team of researchers, clinicians, and mothers who have personal experience with depression, to support women experiencing depression during pregnancy and the postpartum period. We call this program Alma because the meaning of the word, in English and Spanish, captures what we hope moms will feel when they connect with this program. In English, the meaning comes from the Latin word for "nourishing" and "kind," and in Spanish, the meaning is "soul." Through the unique synergy of science and community, the Alma program provides the tools and support needed to nourish moms in supporting their own well-being.

In the Alma program, mothers who themselves have experienced and recovered from depression during the perinatal period, are trained to provide peer mentoring to depressed new and expectant mothers. Peer mentors are trained to provide 6-10 mentoring meetings with each of the new and expectant mothers with whom they are paired. The peer mentors are trained by professionals who are experts in using skills to recover from depression. These skills are informed by an evidence-based framework called Behavioral Activation (BA). Peer Mentors are trained to support and encourage self-monitoring, scheduling activities, solving problems, and bridging to informal and formal professional support. Peer mentors draw on their training and own lived experience to provide hope and reduce the social isolation and stigma associated with perinatal depression. Among the evidence-based approaches to help people recover from depression, Alma uses BA as a lens because many studies have demonstrated that these skills are effective in recovering from depression. It has been provided in a self-guided format and by lay counselors and licensed mental health providers. Peer mentors do not provide psychotherapy and are not licensed mental health providers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 28, 2020
• Est. primary completion date: April 28, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Currently enrolled member of Kaiser Permanente of Colorado (KPCO)

• Current PHQ-9 score greater than or equal to 10

• Current Columbia-Suicide Severity Rating Scale (C-SSRS) score less than 3

• Currently pregnant

Exclusion Criteria:

• Lifetime diagnosis of bipolar disorder or psychotic symptoms

• Dementia or cognitive impairment disorder recorded in the medical record

• Current substance abuse behavior

• At immediate risk of self-harm

• Unable to speak and read English

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder

Intervention

Behavioral:
• Alma
Alma peer-mentoring

Locations

Country	Name	City	State
United States	Kaiser Permanente of Colorado	Aurora	Colorado
United States	University of Colorado Boulder	Boulder	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Boulder	Emory University, Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Patient Health Questionnaire (PHQ-9) score	Self-report measure of depression symptoms.	Every 2 weeks for the first 12 weeks of the study, then monthly until 3-months postpartum
Secondary	Change in Generalized Anxiety Disorder Questionnaire (GAD-7) score	Self-report measure of generalized anxiety symptoms.	Every 2 weeks for the first 12 weeks of the study, then monthly until 3-months postpartum
Secondary	Change in Perceived Stress Scale (PSS-10) score	Self-report measure of stress.	Baseline, 12-weeks post-randomization, 3-months postpartum
Secondary	Change in WHO Disability Assessment Schedule (WHODAS 2.0) score	Self-report measure of health, disability, and functioning.	Baseline, 12-weeks post-randomization, 3-months postpartum
Secondary	Parenting Stress Index-Short Form (PSI-4/SF)	Self-reported stress in the parent-child system.	3-months postpartum
Secondary	Change in Behavioral Activation for Depression Scale (BADS) score	Self-report questionnaire that assesses activation in daily life: Activation, Avoidance/Rumination, Work/School Impairment, and Social Impairment.	Baseline, 12-weeks post-randomization, 3-months postpartum
Secondary	Change in Reward-Probability Index (RPI) score	Self-report questionnaire that assess proxy dimensions of response-contingent positive reinforcement: reward probability and environmental suppressors inhibiting access to reinforcement.	Baseline, 12-weeks post-randomization, 3-months postpartum
Secondary	Change in Environmental Reward Observation Scale (EROS) score	Self-report questionnaire that assess the experience of environmental reward over the past several weeks.	Baseline, 12-weeks post-randomization, 3-months postpartum
Secondary	Change in Attitudes Toward Motherhood (AToM) score	Self-report questionnaire that assess women's attitudes about motherhood, including beliefs related to others' judgments, beliefs about maternal responsibility, and maternal role idealization.	Baseline, 12-weeks post-randomization, 3-months postpartum
Secondary	Working Alliance Inventory - Short Form (Intervention group only)	Self-report questionnaire that assess participant's working alliance with their peer mentor.	12-weeks post-randomization
Secondary	Change in Self- Compassion Scale (SCS) score	Self-report measure of self-compassion.	Baseline, 12-weeks post-randomization, 3-months postpartum
Secondary	Mother Inventory of Reward Experiences (MIRE)	Self-report questionnaire assessing reward responsivity in parenting.	3-months postpartum
Secondary	Change in Social Support Questionnaire - Short Form (SSQ-SF) score	Self-report questionnaire assessing social support available to a participant and their perception of the quality of that social support.	Baseline, 12-weeks post-randomization, 3-months postpartum
Secondary	Client Satisfaction Questionnaire (CSQ-8)	Self-report measure of general satisfaction with the Alma program. Participants randomized to treatment as usual will receive a CSQ-8 to measure general satisfaction with Kaiser Permanente of Colorado mental health services.	12-weeks post-randomization
Secondary	Change in Effort-Expenditure for Rewards Task (EEfRT) performance	Computerized behavior task administered remotely that assesses effort-based decision-making.	Baseline, 12-weeks post-randomization, 3-months postpartum
Secondary	Change in Experience Sampling Survey response	Momentary mood and activity assessed by self-report triggered by text-message prompt to complete a survey.	Baseline, 12-weeks post-randomization, 3-months postpartum
Secondary	Change in Go/No-Go Task (GNAT) performance	Computerized behavior task administered remotely that assesses implicit associations pairing the self with both stigma and belonging.	Baseline, 12-weeks post-randomization, 3-months postpartum
Secondary	Exit Interview	An Exit Interview will be administered to solicit participant feedback about the Alma program and recommendations for improvement, including questions about overall program and specific Alma components, including telephone- or videoconference- based delivery, length and number of sessions, spacing between sessions, peer characteristics, and ease of access to peers.	3-months postpartum

External Links

•   Study information website for potential participants.